QC Specialist I

3 days ago

Singapur, Singapore Novartis Full time

Summary

Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP’s and local/international regulations.

About the Role Key Responsibilities:
  • Ox/Deviation handling.
  • CAPA definition and KPI trending - Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release).
  • Stability - Stability testing (Projects) – protocol preparation, evaluation, report preparation.
  • Reporting (Stability plan preparation, trend analysis, evaluation) - Performance of Stability studies, protocols and comparative reports for supplier qualification - Review and approval of analytical tests (analytical release) - Microbiological QC - Perform microbiological testing of materials and utilities, environmental and personnel monitoring - Provide expert support for site qualification and validation activities - Maintain and calibrate equipment incl. plan preparation - Support in supplier qualification - Trending and analysis of KPI/KQI - Support sample planning and sampling execution - Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable)
  • Comply with all HSE guidelines
  • Detect and report potential accidents, risks and propose solutions
  • Participate in HSE risk assessments
  • Preparation and participation in internal HSE audits
  • Responsible for participating in initial training and retraining

Essential Requirement:

  • Professional experience (6+ years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent; Collaborating across boundaries; Functional breadth; efficient inter- and intra-departmental communications.
  • Collaboration; result oriented. Breakthrough analysis; being resilient; operational excellence; continuous learning; digital & tech savvy
  • MS Office applications and other standard IT applications supporting Quality activities
  • Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory excellence; Quality decision making

Desirable Requirement:

  • Technical education & 3-5 years relevant experience or University degree in Microbiology, Biochemistry or equivalent + 0-4 years working experience.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

Division: Operations | Business Unit: Innovative Medicines | Location: Singapore, Tuas South Avenue | Company / Legal Entity: SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd | Functional Area: Quality | Job Type: Full time | Employment Type: Regular | Shift Work: No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#J-18808-Ljbffr

  • QC Specialist I

    3 days ago

    Singapur, Singapore Novartis Singapore Full time

    Join to apply for the QC Specialist I - Analytical role at Novartis Singapore . This role is responsible for establishing and ensuring testing of drug substance release and stability testing, including testing of intermediates in process control samples. Laboratory operations must comply with written testing SOPs and local/international regulations. About...

  • QC Specialist I

    3 days ago

    Singapur, Singapore Novartis Singapore Full time

    Summary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP’s and local/international regulations. About The Role Key Responsibilities: OOx/Deviation handling . CAPA definition -KPI trending -Ensure all...

  • QC Specialist

    3 days ago

    Singapur, Singapore MIRXES PTE. LTD. Full time

    MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights...

  • QC Supervisor

    3 days ago

    Singapur, Singapore Dingdong Fresh Full time

    Overview Global Recruitment Director | RHR International (Renrui) We Are Hiring: Quality Control Supervisor & Specialists – Fresh Produce (Singapore) Dingdong Maicai (叮咚买菜), a fast-growing fresh grocery e-commerce company, is expanding our Warehouse & Logistics team in Singapore . We are looking for passionate Quality Control Supervisor (1) and...

  • QC Specialist

    3 days ago

    Singapur, Singapore BioSpace Full time

    Overview Join to apply for the QC Specialist role at BioSpace GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Established in 2002, GenScript has a global presence across North America, Europe, the Greater China, and Asia Pacific. Its businesses cover four major areas based on gene synthesis technology, including Life...

  • QC Specialist

    3 days ago

    Singapur, Singapore Smith & Associates Full time

    Responsibilities Visually inspect parts before being shipped to customers – checking for correct part, part number, quantity, any potential damage, etc. Interpret spec sheet Generate discrepancy reports Tape and reel duties Interface with procurement specialists and account reps to resolve any issues with material received or shipped Support...

  • Senior Specialist

    3 days ago

    Singapur, Singapore Advanz Pharma Full time

    Senior Specialist - Quality Hypercare (Biosimilars QC) The Senior Specialist, Biosimilars at ADVANZ PHARMA will provide technical support to the Associate Director, Biosimilar Quality on all aspects of biological products and the development and enhancement of the Pharmaceutical Quality System to ensure it meets Health Authority expectations. The portfolio...

  • English Teacher

    3 days ago

    Singapur, Singapore I Can Read Full time

    I Can Read is recruiting qualified English Language Teachers who are passionate about and committed to helping young children to reach their literacy goals. We are a leading international literacy-based learning organisation with more than 20 years of experience in the education field. Head-quartered in Singapore, I Can Read has an incredibly diverse and...

  • Frontline Customer Experience Part time I Orchard I SGD12 per hour

    3 days ago

    Singapur, Singapore Decathlon Singapore Full time

    Frontline Customer Experience Part time I Orchard I SGD11.5 per hour Frontline Customer Experience Part time I Orchard I SGD11.5 per hour 4 weeks ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by Decathlon Singapore. Your actual pay will be based on your skills and experience —...

  • Quality Control Analyst

    3 days ago

    Singapur, Singapore Manpower Singapore Full time

    Quality Control Analyst (QC/Food Science/Contract) Join to apply for the Quality Control Analyst (QC/Food Science/Contract) role at Manpower Singapore Quality Control Analyst (QC/Food Science/Contract) Join to apply for the Quality Control Analyst (QC/Food Science/Contract) role at Manpower Singapore Conduct conformance test on raw materials and finished...